Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:47 PM
Study NCT ID:
NCT04929769
Status:
RECRUITING
Last Update Posted:
2021-11-01
First Post:
2021-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-21', 'size': 1310557, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-25T08:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 780}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2026-09-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2021-06-10', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Analysis of continuous outcomes', 'timeFrame': '1 years from surgery', 'description': 'Compare these between groups(The continuous outcomes include operative duration, anesthesia time, blood loss during operation, postoperative pain score and postoperative hospital stay.)'}, {'measure': 'Analysis of binary outcomes', 'timeFrame': '5 years from surgery', 'description': 'Compare these between groups(The intraoperative complications, postoperative complications, one-month and one-year postoperative quality of life and sexual life will be treated as binary outcomes and will be summarised by number (%) of participants with the event.)'}, {'measure': 'Safety analysis', 'timeFrame': '5 years from surgery', 'description': 'Adverse events (AEs) will be summarised using the number of AEs, the number (%) of participants with AEs by groups.'}], 'primaryOutcomes': [{'measure': 'the rate of PFS at 5 years', 'timeFrame': '5 years from surgery', 'description': 'The curves of PFS at 5 years will be estimated using the Kaplan-Meier method. The logrank test will be used to test the above hypothesis, the 5-year PFS rate difference and its 95% confidence interval (CI) for the comparison between the two groups will be estimated.'}], 'secondaryOutcomes': [{'measure': 'the rate of OS at 5 years', 'timeFrame': '5 years from surgery', 'description': 'Cox proportional hazards model will be used to estimate the hazard ratio and 95% CI for the effect of treatment on the 5-year OS rate.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical Cancer', 'Abdominal Radical Hysterectomy', 'Laparoscopic Radical Hysterectomy'], 'conditions': ['Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '35395868', 'type': 'DERIVED', 'citation': 'Wu X, Qiu L, Lou W, Wang X, Zhu T, Zhang Y, Hu W, Xue X, Zhu Z, Xiang L, Li J, Fang X, Gao S, Feng H, Diao W, Zhang H, Du M, Bai Y, Hou Y, Yan W, Feng H, Yu H, Zhu S, Du Y, Jiang H. A multicenter non-inferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stages IB1, IB2, and IIA1): study protocol of the LAUNCH 2 trial. Trials. 2022 Apr 8;23(1):269. doi: 10.1186/s13063-022-06245-5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IB1, IB2, IIA1).', 'detailedDescription': 'The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB1, IB2, IIA1), by a multicenter stratified randomized controlled study, mainly including the following aspects:\n\n1. To compare the differences in PFS and OS between patients receiving LRH and ARH.\n2. To investigate whether PFS and OS in LRH can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes).\n3. To assess postoperative complications and quality of survival.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB1,IB2,IIA1).\n2. Age ≥ 21 years and ≤ 70 years.\n3. Surgery type B and C (refer to Q-M surgical staging)\n4. Normal range of liver and kidney function and blood count (specific details below) Hemoglobin \\> 60g/L Platelets \\> 70\\*109/L Leukocytes \\> 3\\*109/L Creatinine \\< 50mg/dL Transaminase abnormal indicators ≤ 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value.\n5. No history of other malignancies.\n6. Non-pregnancy.\n7. Physical strength classification: Karnofsky score ≥ 60;\n8. Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up.\n9. No psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, HIV infection, etc.) (Note: Maximum diameter measurement of cervical lesions is based on PET-CT, or CT, or MRI)\n\nExclusion Criteria:\n\n1. Those who are contraindicated for various surgeries and cannot undergo surgery.\n2. Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer.\n3. Patients with recurrent cervical cancer\n4. Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter \\>2cm after further improvement of preoperative examination.'}, 'identificationModule': {'nctId': 'NCT04929769', 'acronym': 'LAUNCH 2', 'briefTitle': 'Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)', 'organization': {'class': 'OTHER', 'fullName': 'Obstetrics & Gynecology Hospital of Fudan University'}, 'officialTitle': 'A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)', 'orgStudyIdInfo': {'id': 'FUOBGY2021-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'the group of LRH', 'interventionNames': ['Other: Total Laparoscopic or Robotic Radical Hysterectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'the group of ARH', 'interventionNames': ['Other: Total Abdominal Radical Hysterectomy']}], 'interventions': [{'name': 'Total Laparoscopic or Robotic Radical Hysterectomy', 'type': 'OTHER', 'description': 'Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.', 'armGroupLabels': ['1']}, {'name': 'Total Abdominal Radical Hysterectomy', 'type': 'OTHER', 'description': 'Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Wu, PHD', 'role': 'CONTACT', 'email': 'wuxin_fc@fudan.edu.cn', 'phone': '8613764046908'}], 'facility': 'The Obstetrics and Gynecology Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xin Wu, PHD', 'role': 'CONTACT', 'email': 'wuxin_fc@fudan.edu.cn', 'phone': '(021)33189900-6529'}, {'name': 'Jiang Hua, PHD', 'role': 'CONTACT', 'email': 'jianghua@fudan.edu.cn', 'phone': '(021)33189900-6529'}], 'overallOfficials': [{'name': 'Xin Wu, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Obstetrics and Gynecology Hospital of Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Obstetrics & Gynecology Hospital of Fudan University', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'Taizhou Hospital, Affiliated Cancer Hospital of the University of Chinese Academy of Sciences', 'class': 'UNKNOWN'}, {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}